Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Comtan

Descriptions


Entacapone is used in combination with levodopa/carbidopa to treat Parkinson's disease, sometimes referred to as shaking palsy. Some patients experience signs and symptoms of end-of-dose “wearing-off” effect despite taking levodopa/carbidopa. Entacapone enhances the effect of levodopa/carbidopa. By improving muscle control, this medicine allows more normal movements of the body.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients. There is no identified potential use of entacapone in children.

Geriatric

Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. In studies done to date that included elderly people, entacapone did not cause different side effects or problems in older people than it did in younger adults.

Pregnancy

Information about this entacapone-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Apomorphine
  • Bitolterol
  • Desipramine
  • Dobutamine
  • Dopamine
  • Epinephrine
  • Iproniazid
  • Isocarboxazid
  • Isoetharine
  • Isoproterenol
  • Linezolid
  • Methyldopa
  • Nialamide
  • Norepinephrine
  • Pargyline
  • Phenelzine
  • Procarbazine
  • Tranylcypromine
  • Venlafaxine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Liver problems—Side effects of entacapone may be increased because of a slower removal from the body.

Proper Use

Take this medicine only as directed by your doctor, to help your condition as much as possible. Do not take more or less of it, and do not take it more or less often than your doctor ordered.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Entacapone is always used in combination with levodopa/carbidopa (Sinemet); never alone.

The number of times a day you take the tablets depends on how often you take levodopa/carbidopa (Sinemet).

  • For oral dosage form (tablets):
    • For Parkinson's disease:
      • Adults—200 mg with each levodopa/carbidopa (Sinemet) dose. Entacapone may be taken up to 8 times a day, but the total daily dose is usually not more than 1600 mg..
      • Children— Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not stop taking entacapone without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Nausea may occur, especially when you first start taking this medicine. Also, an increase in body movements and twitching, twisting, or uncontrolled movements of the tongue, lips, face, arms or legs may occur. Your doctor may need to adjust your dose of levodopa/carbidopa if these movements occur.

This medicine may cause some people to become dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If you should have this problem, check with your doctor.

Hallucinations (seeing, hearing, or feeling things that are not there) may occur in some patients.

Entacapone may cause your urine to turn brownish orange. This effect is harmless and will go away after you stop taking the medicine.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

  1. Absence of or decrease in body movements
  2. hyperactivity
  3. increase in body movements
  4. seeing, hearing, or feeling things that are not there
  5. twitching
  6. twisting
  7. uncontrolled repetitive movements of tongue, lips, face, arms, or legs

Less common

  1. Fever or chills
  2. cough or hoarseness
  3. lower back or side pain
  4. painful or difficult urination

Rare

  1. Confusion
  2. muscle cramps
  3. pain
  4. shortness of breath
  5. stiffness
  6. weakness
  7. unusual tiredness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  1. Abdominal pain
  2. constipation
  3. diarrhea
  4. dizziness
  5. fatigue
  6. nausea

Less common

  1. Acid or sour stomach
  2. anxiety
  3. belching
  4. bruising
  5. burning feeling in chest or stomach
  6. heartburn
  7. difficult or labored breathing
  8. dry mouth
  9. indigestion
  10. insomnia
  11. irritability
  12. loss of strength or energy
  13. muscle pain or weakness
  14. nervousness
  15. passing gas
  16. sleepiness or unusual drowsiness
  17. small, red spots on skin
  18. stomach discomfort, upset or pain
  19. sweating increased
  20. restlessness
  21. tenderness in stomach area
  22. tightness in chest
  23. tremor
  24. shortness of breath
  25. unusual or unpleasant (after) taste
  26. unusual weak feeling
  27. wheezing

This medicine may cause your urine to turn brownish orange. This effect is harmless and will go away after you stop taking the medicine.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.